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About the Role
As a Senior Clinical Trial Specialist (Sr. CTS) at Maze Therapeutics, you’ll play a key role in supporting our Clinical Operations team as we deliver an exciting clinical trial in the rare disease, Phenylketonuria (PKU). You’ll collaborate closely with internal teams, CROs, and vendors to ensure the smooth execution of our clinical studies. This role is best suited for someone who is organized, detail-oriented, and proactive. The ideal candidate enjoys problem-solving, thrives in a fast-paced environment, and is eager to take ownership of critical trial activities such as vendor and site management.
Responsibilities
- Partner with the Clinical Operations team to oversee and monitor the conduct of our global Phase 2 PKU study, monitoring and tracking progress, identifying trends or issues, and collaborating with Study Leads to implement corrective actions when necessary.
- Lead site management oversight to ensure CRO activities align with the study plans and protocol.
- Facilitate any deviation discussions for quick resolution.
- Identify site trends, opportunities for training, and creating tracking tools to ensure sponsor oversight.
- Manage one or more clinical trial vendors from study-start to close-out, including day-to-day management, budget oversight, and escalating to Study Lead as appropriate.
- Identify gaps quickly, hold vendors/CRAs accountable, provide solutions, and escalate risks in a timely manner.
- Ensure that all clinical trial activities adhere to ICH/GCP Guidelines, study plans and protocols, and Maze SOPs.
- Assist in the design, development, and review of study documents, including protocols, informed consent forms (ICFs), amendments, and content creation for study materials.
- Attend and contribute to vendor meetings, lead resolution of study-related issues, and foster a culture of continuous process improvement with CROs and other external partners.
- Oversee Trial Master File (TMF) activities, ensuring proper documentation, metric tracking and reconciliation efforts as needed.
- Work with study team to coordinate and track sample shipments, sample analysis, and data reconciliation efforts.
- Serve as a point of contact for study-related inquiries and provide high-level administration, coordination, and organizational support to the Clinical Operations team.
- Contribute to creation and refinement of Clinical Operations standard operating procedures (SOPs) and process documents to optimize study execution.
Requirements
- Bachelor’s degree with 2-3+ years of experience in Clinical Operations within a biotech or pharmaceutical environment.
- Willingness to travel up to 10-15%, with the possibility of more based on project needs.
- Strong computer proficiency (Microsoft Office Suite- Word, Excel, Outlook).
Skills
- Systematic and problem-solving mindset
- Exceptional organizational skills
- Proactive and collaborative approach
- Hands-on experience with clinical trial databases such as Medidata Rave, Veeva, or similar platforms
- Flexibility and adaptability
- Ability to manage multiple priorities
- Detail-oriented
- Ability to keep trials on track
- Ability to take initiative
- Ability to build meaningful relationships with internal and external partners
- Willingness to roll-up your sleeves to perform a broad range of clinical trial related tasks as needed.
Location
- South San Francisco, CA
Work Type
- Hybrid
Experience Level
- Senior
Education Level
- Bachelor's degree
Salary/Compensations
- $125,000 to $152,000
- Eligible for an annual performance bonus
Benefits
- Competitive medical, dental, and vision insurance
- Mental health offerings
- Equity incentive plan
- 401(k) program with employer match
- Generous holiday and PTO policy
About the Company
- Maze Therapeutics is a clinical-stage biopharmaceutical company harnessing human genetics to develop precision medicines for patients with kidney and metabolic diseases.
- Our clinical pipeline is anchored by two small molecule programs: MZE829, an APOL1 inhibitor for patients with APOL1‑mediated kidney disease, and MZE782, which targets genetic drivers of disease in phenylketonuria (PKU) and chronic kidney disease.
- We are also advancing a preclinical pipeline through our Compass platform, which links human genetic variants to the biological pathways that drive disease.
- Maze is comprised of a team of passionate and creative professionals committed to discovering and delivering transformative medicines to patients suffering from both rare and common genetic diseases.
- We are fostering a culture that encourages vision, initiative and the development of talent.
- Our supportive work environment inspires creative thinking and freedom of expression, resulting in a stimulating atmosphere where people enjoy coming to work.
- While we have a passion for advanced science and pride ourselves on excellence in execution, ultimately, everything we do is about patients.
Equal Opportunity
- Further Together – Our path is paved with challenges, but with resilience and a team-first mentality, we’ll achieve our mission.
- Impact Obsessed – We embrace the bold, take calculated risks, and learn from our mistakes to improve the lives of others.
- Stand True – Our integrity is foundational; it guides us no matter the obstacle.